Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product

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Current effective version

Reflection paper

Reference numberEMA/CHMP/SWP/620008/2012
Published27/03/2015
KeywordsNano-sized colloidal intravenous iron preparation, similarity, reference medicinal product, pharmaceutical, non-clinical, clinical, characterisation, tissue bio-distribution
DescriptionThis document assists in the generation of relevant quality, non-clinical and pharmacokinetic clinical comparative data to support a marketing authorisation for an intravenous iron-based nano-colloidal product developed with reference to an innovator product.


Document history

First version

Current version

Reflection paper


Overview of comments


Draft reflection paper

Published: 27/03/2015


Published: 27/03/2015


Published: 16/09/2013

Superseded documentReflection paperPublished: 07/04/2011


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